Surveillance for Multifocal GGNs

Active Surveillance for Patients with Multifocal Ground-glass Nodules: a Prospective, Multi-center, Single-arm Trial (ECTOP-1021)

This study is a single-arm, multi-center, phase III trial conducted under the Eastern Cooperative Thoracic Oncoloy Project (ECTOP) with the identification number ECTOP-1021. The primary objective of the study is to assess the overall survival of patients with multifocal ground-glass opacities by employing a active surveillance approach rather than opting for surgical resection.

Study Overview

• Status: Recruiting
• Conditions: Active Surveillance; Lung Ground-glass Opacities
• Intervention / Treatment: Procedure: Watchful waiting

Detailed Description

The trial aims to confirm the hypotheses that delaying surgery until GGO nodules exhibit progression or meet certain criteria offers a prognosis equivalent to those undergoing immediate surgical resection, potentially allowing many of these patients to avoid surgery altogether.

• Study Type: Observational
• Enrollment (Estimated): 370

Contacts and Locations

• Study Contact: Name: Haoxuan Wu, Dr.; Phone Number: 63189 86-021-64175590; Email: haoxuanwu@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Cancer Center
      • Contact: Chen Haiquan, MD; Phone Number: 1707 +86-21 64175590; Email: hqchen1@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Outpatients who are willing to particiapte in the study and meet the inclusion and exculsion criteria.

Description

Inclusion criteria Patients eligible for enrollment in the study are required to meet all the following criteria.

1. Demonstrates the following on thin-section computed tomography (TSCT) scan:

   1. Presence of three or more GGNs (bilateral lesions are permitted).
   2. All lesions have remained stable without regression or enlargement for at least 3 months.
   3. The dominant lesion (the lesion with the largest maximum tumor diameter) has a maximum tumor diameter >=0.6cm and <=2cm.
   4. CTR <=0.25 in all lesions.
   5. No lymph node with a diameter >1cm in the mediastinal view.
   6. Not adjacent to the pleura in dominant lesion and no sign of pleural retraction in any lesions.
2. Aged 18-75 years.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Has not previously undergo any anti-tumor drug or radiation therapy.
5. Written informed consent.

Exclusion criteria Patients will be excluded if they meet any of the following criteria.

1. History of any prior malignancies within the past 5 years.
2. History of lung surgery.
3. History of interstitial pneumonia, pulmonary fibrosis or other severe pulmonary diseases.
4. Presence of severe or uncontrolled diseases that may possibly reduce the 10-year life expectancy.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observation	Procedure: Watchful waiting; Conduct thoracic computed tomography scans every 12 months. The decision regarding surgery is based on the surgeon's evaluation of radiologic follow-up. The reference resection criteria encompass: a) Any lesion that progresses to a tumor diameter larger than 2cm or has CTR greater than 0.25. b) Clinical Tumor, node, metastasis (TNM) stage upstaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-year overall survival	The event is defined as the death due to any causes.	5 years

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): November 1, 2036
• Study Completion (Estimated): November 1, 2036

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 29, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ECTOP-1021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The clinical data including patient characteristics and CT images.
• IPD Sharing Time Frame: Within five years from the study end.

IPD Sharing Access Criteria

Medical oncologists and surgeons who are interested in the study. Emails could be sent to the address below to obtain the shared data:

hqchen1@yahoo.com

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No